The Clinical Study of Injection of Freshly Prepared HA35 for Treatment Gingivitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Measurement of gum discomfort
研究概览
简要总结
Preliminary clinical studies have confirmed that injection of freshly prepared HA35 can reduce symptoms and signs of gingivitis or periodontitis. This clinical study is a prospective repeated experiments. The purpose of this study was to verify the effectiveness of HA35 injection therapy.
详细描述
The previous studies showed that toothpastes containing the cosmetic grade raw material of the 35 kDa low molecular hyaluronan fragment HA35 significantly reduced symptoms and signs of gingivitis or periodontitis. In this study, patients with mild to moderate periodontitis suffering from symptoms and signs, including discomfort and swelling and bleeding of periodontal tissue, were treated by intrapocket injection of freshly manufactured hyaluronan fragment HA35. This study is an repeat clinical study comparing pre- and posttreatment effects similar to others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy condition and with a clinical diagnosis of mild to moderate gingivitis.
- •Male or female volunteers aged 18-60 years.
- •Gingival Index (GI) from 1 to 2 (0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing)
排除标准
- •Healthy condition and with a clinical diagnosis of severe gingivitis.
- •Pregnant or lactating females.
- •Be concomitantly participating in another clinical study.
- •History of any allergic reaction to HA.
- •To treat the gingivitis with any other medication/mouthwashes in the period of the study.
研究组 & 干预措施
HA35 local injection of Periodontal Pocket group
The tissue-permeable 35 kDa low molecular hyaluronan fragment HA35 was freshly manufactured using pharmaceutical grade hyaluronidase PH20 injection (State Drug Administration H31022111) and joint cavity HA injection (State Drug Administration H20174089) mixed at room temperature for 20 min.
干预措施: Freshly manufactured 35 kDa hyaluronan fragment (Drug)
结局指标
主要结局
Measurement of gum discomfort
时间窗: 7 days
Each patient rated their gingival discomfort or itching on a scale of 0 to 10. 0 means "no", and 10 means "the most".
Measurement of gum redness and swelling
时间窗: 7 days
The physician used the numbers 0-10 to rate the intensity of gingival redness and swelling in the subject. 0 means "no"; 10 means "highest".
Measurement of probe gingival bleeding
时间窗: 7 days
The physician used the numbers 0-10 to rate the extent to which the subject's probe gums were bleeding. A score of 0 indicated "no" and 10 indicated "the most"
次要结局
未报告次要终点